FDA product code IJZ: Oil, Clearing
IJZ is the FDA product code for oil, clearing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under IJZ. The average 510(k) review took 37 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Oil, Clearing |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | HE — Hematology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IJZ clearance
Top IJZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Canon USA, Inc. | 1 | 1985-10-24 |
Most recent IJZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K853861 | Canon USA, Inc. | CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 | 1985-10-24 | 37 |
Recalls for IJZ devices
openFDA lists no recalls for product code IJZ.
Frequently asked questions
What is FDA product code IJZ?
IJZ is the FDA product code for oil, clearing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Hematology panel.
What device class is IJZ?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IJZ?
Across 1 cleared submissions the average was 37 days from receipt to decision (median 37).
Which companies have the most IJZ clearances?
Canon USA, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IJZ
- Run a recall and safety report across every IJZ manufacturer
- Watch product code IJZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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